NCT01331395终止不适用
A Randomized, Controlled Clinical Trial of the Effect of Traditional Chinese Medicine on IVF Success Rates
Pacific Fertility Center0 个研究点目标入组 8 人开始时间: 2011年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 主要终点
- The proportion of subjects in the active treatment group experiencing no SAE's attributable to ACU.
研究概览
简要总结
The purpose of this study is to determine the value of combining Traditional Chinese Medicine (TCM) Protocols including acupuncture with In Vitro Fertilization (IVF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject is able to understand and provide consent
- •Subject is female, 21-42 years of age at time of screening and has at least one l ovary
- •Subject BMI is > 18 and < 32
- •Subject is experiencing primary or secondary infertility
- •Subject may receive sperm from donated source
- •Subject's partner has sperm in the ejaculate
- •Subject's serum basal FSH is < 11 IU/L
- •Subject's serum basal estradiol level is between 20-80 pg/mL
- •Subject's TSH level is < 3.0 mv/mL
- •Subject's prolactin level is < 24 ng/mL
- •Subject will agree to limit caffeine intake to one cup (76.5 mL/day) by the time of randomization
- •Subject agrees not to make alterations in diet and lifestyle practices other than those that their Medical Practitioner deems necessary in the best interest of the subject
- •Subject agrees not to participate in any other research opportunities for the duration of the study
排除标准
- •Subject is pursuing sex selection
- •Subject is undergoing treatment with an egg donor
- •Subject experienced more than 2 previous failed cycles
- •Subject is undergoing a heparin or lovenox-based protocol
- •Subject is currently taking herbal therapy (1 week wash-out)
- •Subject is currently taking co-interventions of moxibustion and cupping
- •Subject is exhibiting uterine anomalies (i.e.,bicornuate, unicornuate uterus,)
- •Subject is diagnosed with severe endometriosis defined as endometriomas > 4cm
- •Subject is currently receiving acupuncture therapy (Subject must agree to a 30 day washout period prior to randomization)
- •Subject has history of recurrent spontaneous abortions defined as > 3
- •Subjects with a Beck Depression Inventory (BDI-II) of 29 or higher at screening, indicative of severe depression, will be excluded from the study and referred for further psychological evaluation by our in-house licensed mental health professional.
结局指标
主要结局
The proportion of subjects in the active treatment group experiencing no SAE's attributable to ACU.
时间窗: Overall to be collected at interim analysis of 138 subjects and at study completion of 276 patients
The proportion of subjects who receive an embryo transfer which results in a live birth.
时间窗: Average of 1 year
Embryo transfer resulting in Live Birth up to 40 weeks gestation
次要结局
- Effect of the IVF/ICSI treatment on quality of life and psychological factors assessed with the Fertility Quality of Life Questionnaire (FertiQoL 2008) and the Spielberger State Trait Anxiety Inventory (STAI).(Average of two months)
- 1. The proportion of subjects who undergo an embryo transfer which results in implantation as evidenced by USS at 7 weeks.(Average of 4 months)
研究者
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